The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).
ViiV Healthcare made regulatory submissions to the EMA and the U.S. FDA for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen).
Ocular Therapeutix’s NDA resubmission for DEXTENZA 0.4 mg for ocular pain occurring after ophthalmic surgery was accepted as a filing for review by FDA.
Eagle Pharmaceuticals Inc. announced that it has completed the submission of its 505(b)(2) New Drug Application for Ryanodex for the treatment of exertional heat stroke (EHS) to the U.S. Food and Drug Administration.
New timelines were announced for a U.S. FDA decision on Iglarlixi, the fixed-ratio combination of Adlyxin (lixisenatide) and Lantus, for treating type 2 diabetes.
Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE in Europe, Canada and certain other international markets; OPKO Health to receive up to $282 million in upfront and milestone payments, plus tiered double-digit royalties.
LONDON – Looking to strengthen its cardiovascular and metabolic offerings, London-based AstraZeneca (AZN) is snapping up Bay Area-based ZS Pharma (ZSPH) in a deal worth $2.7 billion in hopes of leveraging that company’s ion-trap technology treatments for hyperkalemia into a blockbuster drug. The deal, which will see AstraZeneca spend $90 per share for ZS Pharma, […]
PHILADELPHIA, Oct. 19, 2015 /PRNewswire/ — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016. Calcitonin has been available as […]